FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71610-347
11-digit product format
716100347
Labeler code
71610
Product ID
71610-347_e0a0e6d9-bdfb-42d0-b113-2ef3f2b20529
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204010
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-347-302023-01-30C16284748780-1f386c649-db6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use oxybutynin chloride extended-release tablets safely and effectively. See full prescribing information for oxybutynin chloride extended-release tablets. OXYBUTYNIN chloride extended-release tablets, USP for oral use. Initial U.S. Approval: 1975
71610-347-602023-01-30C16284748780-1f386c649-db6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use oxybutynin chloride extended-release tablets safely and effectively. See full prescribing information for oxybutynin chloride extended-release tablets. OXYBUTYNIN chloride extended-release tablets, USP for oral use. Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-347-30Oxybutynin Chloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301
71610-347-60Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-347-30EA - Each71610-34707fd9dca-d8f3-4c69-823f-72bd84a92b8a12019-11-12
71610-347-60EA - Each71610-34707172c12-91c7-41fe-81fc-b73b134922db12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-347OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20191017_73408fe2-f301-4a5e-b501-f331e7a84f8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN73408fe2-f301-4a5e-b501-f331e7a84f8d1
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD73408fe2-f301-4a5e-b501-f331e7a84f8d1
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY73408fe2-f301-4a5e-b501-f331e7a84f8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-347-307161003473030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-347-30) 2019-09-270000-00-00NoNoCurrent
71610-347-607161003476090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-347-60) 2019-09-270000-00-00NoNoCurrent